POS0699 SIMILAR EFFICACY AND DRUG SURVIVAL RATES OF BARICITINIB MONOTHERAPY AND BARICITINIB/METHOTREXATE COMBINATION THERAPY IN REAL-LIFE TREATMENT OF RHEUMATOID ARTHRITIS - RESULTS FROM A PROSPECTIVE COHORT OF BARICITINIB-TREATED PATIENTS
Authors: S. Bayat, K. Tascilar, D. Bohr, D. Simon, G. Krönke, F. Hartmann, J. Knitza, G. Schett, A. Kleyer
Journal: Annals of the Rheumatic Diseases (2022)

Background In clinical trials, baricitinib (BARI), in combination with methotrexate (MTX), demonstrated efficacy in patients with rheumatoid arthritis (RA) who have not responded adequately to conventional (cs)or biologic (b) DMARDs [1]. Since MTX is often not tolerated very well [2], BARI monotherapy may be preferable over BARI/MTX combination in some patients with RA. Therefore, real-life data on BARI mono- vs. combination therapy are needed to support such decisions. Objectives The aim of our study was to evaluate the efficacy of BARI as mono- or combination therapy in a prospective, open label cohort of RA patients failing previous cs/bDMARD therapy. Methods Patients with active RA (DAS28-ESR &gt;3.2), fulfilling the ACR/EULAR 2010 classification criteria and failing previous cs/bDMARD therapy were included. All patients received BARI either as monotherapy or in combination with MTX based on the judgement of the treating physician. Demographics, medical history, disease activity parameters such as 66/68 TJC/SJC, composite scores such as DAS28-ESR, HAQ-DI, as well as medication were prospectively recorded every 3 months according to a pre-defined protocol. Informed consent and ethics approval (19_18 B) were obtained. To evaluate clinical efficacy, DA28 ESR responses was recorded at respective visit dates (until week 96). We estimated least-square mean DAS-28 scores over time using linear mixed effects models including time-group interactions. Kaplan-Meier method was used to estimate baricitinib survival and probability of remission over time. Results 139 patients (98 women/41 men; aged 58.4 (12.8) years; mean disease duration of 9.7 years) were included between 4/2017-10/2021. Of these, 46 patients received a combination of BARI with MTX (BARI/MTX) and 93 patients BARI monotherapy. Baseline demographic and disease-specific characteristic were comparable between BARI/MTX and BARI patients (Table 1). Median follow up was 53.1 weeks (IQR 23.0-109.3). Decrease in DAS28-ESR showed a similar dynamics in BARI/MTX (baseline DAS28-ESR: 4.2+/-1.3; 48 weeks: 2.9 (95%CI 2.6 to 3.2)) and BARI (4.3+/-1.3; 48 weeks: 3.0 (95%CI 2.8 to 3.3)) with numerical but no significant differences (Figure 1a). 62% (95%CI 40 to 76%) patients in the BARI/MTX group and 51% (95%CI: 37 to 61%) patients in the BARI attained DAS28ESR remission after 48 weeks. Drug survival was comparable among BARI/MTX and BARI patients. (69 vs.67% at 1 year and 62 vs 56% at 2 years) (Figure 1b). Conclusion These data show that BARI monotherapy is efficacious in real life treatment in RA patients with insufficient response to MTX. Clinical efficacy and drug survival is comparable between BARI monotherapy and BARI/MTX combo in a real-life setting. References [1]Genovese, M.C., et al., Baricitinib in Patients with Refractory Rheumatoid Arthritis. N Engl J Med, 2016. [2]Michaud, K., et al., Real-World Adherence to Oral Methotrexate Measured Electronically in Patients With Established Rheumatoid Arthritis. ACR Open Rheumatol, 2019 Acknowledgements The analysis of the data of this study is partially financially supported by Elli Lilly. Disclosure of Interests None declared